Automated filling systems and methods

ABSTRACT

Various embodiments of the present invention are directed to transferring fluidic media from a vial to a reservoir. In various embodiments, fluidic media may be transferred from the vial to the reservoir by moving a housing portion to move a plunger head located in the reservoir to draw fluidic media from the vial to the reservoir. In other embodiments, fluidic media may be transferred from the vial to the reservoir while the reservoir is held by a holding unit and vibrated by a vibrator to remove air from the fluidic media. In some embodiments, fluidic media may be transferred from the vial to the reservoir by moving a handle operatively connected to a bias member for assisting with the transfer of fluidic media. In other embodiments, the transfer of fluidic media may be assisted by a bias member and a needle connecting atmosphere and the vial.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Divisional of U.S. application Ser. No.14/927,378, filed Oct. 29, 2015 which is a Divisional of U.S.application Ser. No. 13/961,798, filed Aug. 7, 2013, which is aDivisional of U.S. application Ser. No. 13/163,548, filed Jun. 17, 2011,which is a Divisional of U.S. application Ser. No. 12/107,580, filedApr. 22, 2008, which is a non-provisional application of U.S.Provisional Application Ser. No. 60/927,032, filed Apr. 30, 2007,entitled “Needle Inserting, Reservoir Filling, Bubble Management, FluidFlow Connections and Infusion Medium Delivery Systems and Methods withSame,” the contents of each of which is incorporated herein by referencein its entirety, and which is a basis for a claim of priority.Embodiments of the present invention relate to PCT InternationalApplication No. PCT/US2007/076641, filed Aug. 23, 2007, the contents ofwhich are incorporated herein by reference in its entirety, and whichclaims the benefit of U.S. Provisional Application Ser. No. 60/927,032,filed Apr. 30, 2007.

BACKGROUND OF THE INVENTION 1. Field of the Invention

Embodiments of the present invention relate generally to systems andmethods with reservoirs and, in specific embodiments, to systems andmethods allowing for automated filling of reservoirs.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have also been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices that are designed to be carried by a patient, or the like.External pump type delivery devices may contain reservoirs of fluidicmedia, such as, but is not limited to, insulin. External pump typedelivery devices may be connected in fluid flow communication to apatient or user, for example, through a suitable hollow tubing. Thehollow tubing may be connected to a hollow needle that is designed topierce the skin of the patient and to deliver fluidic media therethrough. Alternatively, the hollow tubing may be connected directly tothe patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described inthe following references: (i) Published PCT Application WO 01/70307(PCT/US01/09139), entitled “Exchangeable Electronic Cards for InfusionDevices”; (ii) Published PCT Application WO 04/030716(PCT/US2003/028769), entitled “Components and Methods for PatientInfusion Device”; (iii) Published PCT Application WO 04/030717(PCT/US2003/029019), entitled “Dispenser Components and Methods forInfusion Device”; (iv) U.S. Patent Application Pub. No. 2005/0065760,entitled “Method for Advising Patients Concerning Doses Of Insulin”; and(v) U.S. Pat. No. 6,589,229, entitled “Wearable Self-Contained DrugInfusion Device”, each of which is incorporated by reference herein inits entirety.

As compared to syringes and insulin pens, pump type delivery devices canbe significantly more convenient to a patient, in that doses of insulinmay be calculated and delivered automatically to a patient at any timeduring the day or night. Furthermore, when used in conjunction withglucose sensors or monitors, insulin pumps may be automaticallycontrolled to provide appropriate doses of fluidic media at appropriatetimes of need, based on sensed or monitored levels of blood glucose. Asa result, pump type delivery devices have become an important aspect ofmodern medical treatments of various types of medical conditions, suchas diabetes, and the like. As pump technologies improve and doctors andpatients become more familiar with such devices, external medicalinfusion pump treatments are expected to increase in popularity and areexpected to increase substantially in number over the next decade.

SUMMARY OF THE INVENTION

Various embodiments of the present invention are directed to automatedand/or assisted filling systems and methods. A system for transferringfluidic media in accordance with an embodiment of the present inventionmay include, but is not limited to, a first housing portion and a secondhousing portion. The first housing portion may have a latitudinaldimension. The second housing portion may be operatively connected tothe first housing portion. The second housing portion may be for movingrelative to the latitudinal dimension of the first housing portion. Oneof the first and second housing portions may be removably connectable toa transfer guard. The transfer guard may be for providing a fluid pathfrom a vial to a reservoir. The other of the first and second housingportions from said one of the first and second housing portions may beoperatively engageable to a plunger head positioned in the reservoir.The first and second housing portions may be configured such thatfluidic media is transferred from the vial to the reservoir in a casewhere the one of the first and second housing portions is connected tothe transfer guard, and the other of the first and second housingportions is operatively engaged to the plunger head, and the secondhousing portion is moved relative to the latitudinal dimension of thefirst housing portion.

In various embodiments, the first housing portion may have at least onetab insertable into at least one aperture of the transfer guard. Thesystem may further include a plunger arm and a handle. The plunger armmay have a first end and a second end. The first end of the plunger armmay be connectable to the plunger head. The handle may be connected tothe second end of the plunger arm.

In various embodiments, the second housing portion may have a recess.The handle may be insertable into the recess of the second housingportion. The other of the first and second housing portions from saidone of the first and second housing portions may be operatively engagedto the plunger head when the handle is inserted into the recess of thesecond housing portion.

In various embodiments, the system may further include a fill volumecontrol device. The fill volume control device may be supported by theone of the first and second housing portions that is removablyconnectable to the transfer guard. The fill volume control device mayhave a plurality of selectable positions, wherein each selectableposition of the plurality of selectable positions may correspond to avolume of fluidic media to be transferred from the vial to the reservoirwhen the second housing portion moves relative to the latitudinaldimension of the first housing portion. The plunger head may be moveablein the reservoir until the handle contacts the fill volume controldevice.

In various embodiments, the fill volume control device may furtherinclude at least one fill volume tab. The handle may contact the fillvolume control device when the handle contacts one of the at least onefill volume tab. The handle may have at least one aperture. At least oneof the at least one fill volume tab may be insertable into the at leastone aperture of the handle. In some embodiments, each tab of the atleast one tab may be of varying lengths. In some embodiments, each fillvolume tab of the at least one fill volume tab may correspond to aselectable position of the plurality of selectable positions. In someembodiments, the at least one fill volume tab may have a plurality ofedges. Each edge of the plurality of edges may correspond to aselectable position of the plurality of selectable positions. In furtherembodiments, the fill volume control device may be at least partiallyrotatable about the one of the first and second housing portions that isremovably connectable to the transfer guard.

In various embodiments, the system may further include a second handleconnected to the fill volume control device. The second handle may befor rotating the fill volume control device to select a position of theplurality of selectable positions. In some embodiments, the one of thefirst and second housing portions that is removably connectable to thetransfer guard may have an abutment for inhibiting advancement of thesecond handle beyond the abutment. In some embodiments, the system mayinclude protrusions located at each of the plurality of selectablepositions. The protrusions may be for at least partially inhibitingmovement of the second handle.

In various embodiments, the system may include a door operativelyconnected to the second housing portion. In further embodiments, thesystem may further include at least one handle grip located on at leastone of the second housing portion and the door of the second housingportion. In some embodiments, the system may include a door operativelyconnected to the first housing portion. In further embodiments, thesystem may further include at least one handle grip located on at leastone of the first housing portion and the door of the first housingportion.

In various embodiments, the system may include a base located on abottom end of the first housing portion. The system may further includean adhesive pad located on a bottom surface of the base. In otherembodiments, the system may include a friction pad located on a bottomsurface of the base. In some embodiments, the friction pad may comprisea rubber material.

In various embodiments, the system may include a pressure control valvefor providing an air path between the vial and atmosphere.

In various embodiments, the transfer guard may comprise a needle forconnecting the vial and the reservoir. The transfer guard may include afirst end for at least partially surrounding a port of the vial when theneedle of the transfer guard pierces a septum in the port of the vial.In some embodiments, the transfer guard may include a second end for atleast partially surrounding a port of the reservoir when the needle ofthe transfer guard pierces a septum in the port of the reservoir. Infurther embodiments, the transfer guard may further include at least onetab located in at least one of the first end and the second end forsecuring at least one of the vial and the reservoir in the at least oneof the first end and the second end of the transfer guard. In someembodiments, at least one of the first end and the second end may have aplurality of apertures. At least one of the vial and the reservoir mayinclude a plurality of tabs located on the corresponding port. Theplurality of tabs may be insertable into the plurality of apertures ofthe at least one of the first end and the second end of the transferguard. In some embodiments, at least one of the vial and the reservoirmay be at least partially rotatable about the at least one of the firstend and the second end. At least one tab of the plurality of tabs may berotatable from a position within at least one aperture of the pluralityof apertures to a locked position. In further embodiments, the systemmay further include at least one abutment for locking at least one tabof the plurality of tabs into the locked position.

In various embodiments, the system may include at least one seal memberpositioned between the plunger head and the reservoir.

In various embodiments, the second housing portion may have a threadedportion. The transfer guard may have a threaded portion for engaging thethreaded portion of the second housing portion when the transfer guardis connected to the second housing portion. The system may include athreaded member supported by the first housing portion. The plunger headmay have a threaded portion for engaging the threaded member when theplunger head is connected to the threaded member of the first housingportion.

In various embodiments, the second housing portion may be moveablerelative to the latitudinal dimension of the first housing portionbetween at least a first position and a second position. The transferguard may be connectable to the second housing portion while the secondhousing portion is in the second position.

In various embodiments, the system may include a bias member arranged toimpart a bias force on the second housing portion. The bias member maycomprise a spring. The system may further include a latch for supportingthe second housing portion when the second housing portion is in thesecond position and the latch is in a first latch position and forallowing the second housing portion to move to the first position whenthe latch is in a second latch position. In a case where the latch is inthe first latch position, the bias member may be biased toward anexpanded position and is held compressed by the second housing portion.In a case where the latch is in the second latch position, the biasmember may push on the second housing portion so as to move the secondhousing portion to the first position. In some embodiments, the systemmay further include a first button for moving the latch between thefirst latch position and the second latch position. The first button maybe for moving the latch between the second latch position and the firstlatch position. In further embodiments, the system may further include asecond button for moving the latch between the second latch position andthe first latch position.

A method for transferring fluidic media in accordance with an embodimentof the present invention, the method may include, but is not limited to,(i) providing a first housing portion having a latitudinal dimension,(ii) locating a second housing portion operatively connected to thefirst housing portion, the second housing portion for moving relative tothe latitudinal dimension of the first housing portion, (iii)configuring one of the first and second housing portions to be removablyconnectable to a transfer guard, the transfer guard for providing afluid path from a vial to a reservoir, (iv) configuring the other of thefirst and second housing portions from said one of the first and secondhousing portions to be operatively engagable to a plunger headpositioned in the reservoir, and (v) configuring the first and secondhousing portions such that fluidic media is transferred from the vial tothe reservoir in a case where the one of the first and second housingportions is connected to the transfer guard, and the other of the firstand second housing portions is operatively engaged to the plunger head,and the second housing portion is moved relative to the latitudinaldimension of the first housing portion.

In an embodiment for a system for transferring fluidic media, the systemmay include, but is not limited to, a holding unit and a vibrator. Theholding unit may be for holding a reservoir. The holding unit may beconfigured such that a plunger arm that is connected to a plunger headthat is within the reservoir is moveable when the holding unit isholding the reservoir and the reservoir is being filled with fluidicmedia. The vibrator may be for vibrating the holding unit so as tovibrate the reservoir.

In various embodiments, the vibrator may be configured to vibrate theholding unit when the holding unit is holding the reservoir and thereservoir is being filled with fluidic media, so as to vibrate thereservoir and cause air bubbles within the fluidic media to travelupwards within the reservoir. In some embodiments, the vibrator may beconfigured to shake the holding unit sufficiently when the holding unitis holding the reservoir and the reservoir is being filled with fluidicmedia so as to shake air bubbles free in the fluidic media.

In various embodiments, the system may further include a first holderand a second holder. The plunger arm may be moveable within a spacebetween the first holder and the second holder when the reservoir isbeing held by the first holder and the second holder and the reservoiris being filled with fluidic media. The first holder and the secondholder may be connected to the vibrator. In some embodiments, the spacemay be also at least partially between the plunger arm and the vibrator.

In various embodiments, the holding unit may be configured such that,when the holding unit is holding the reservoir, fluidic media isfillable into the reservoir through a port of the reservoir that islocated to an opposite side of said plunger head from said plunger arm.In yet further embodiments, the holding unit may be configured such thatthe plunger arm is moveable in a direction toward the vibrator when theholding unit is holding the reservoir and the reservoir is being filledwith fluidic media.

In various embodiments, the system may further include one or morelatches for preventing the plunger arm from being moved when the holdingunit is holding the reservoir and prior to a time when the reservoir isbeing filled with fluidic media. In further embodiments, the system mayinclude a transfer guard for transferring fluidic media from a vial tothe reservoir when the holding unit is holding the reservoir. Thetransfer guard may include a first end for at least partiallysurrounding a port of the reservoir when a needle of the transfer guardpierces a septum in the port of the reservoir. In yet furtherembodiments, the holding unit may be configured such that a handleconnected to the plunger arm is moveable within a space between thereservoir and the vibrator when the holding unit is holding thereservoir and the reservoir is being filled with fluidic media.

A method for transferring fluidic media in accordance with an embodimentof the present invention may include, but is not limited to, (i)providing a holding unit for holding a reservoir, the holding unitconfigured such that a plunger arm that is connected to a plunger headthat is within the reservoir is moveable when the holding unit isholding the reservoir and the reservoir is being filled with fluidicmedia, and (ii) locating a vibrator for vibrating the holding unit so asto vibrate the reservoir.

In an embodiment for a system for transferring fluidic media, the systemmay include, but is not limited to, a housing portion and a bias member.The housing portion may have a latitudinal dimension. The housingportion may be for supporting a reservoir connectable to a transferguard for providing a fluid path from a vial to the reservoir. The biasmember may be operatively engageable with a handle that is operativelyengageable to a plunger head positioned in a reservoir. The bias membermay be for moving the handle relative to the latitudinal dimension ofthe housing portion. The housing portion and the bias member may beconfigured such that fluidic media is transferred from the vial to thereservoir in a case where the housing portion is supporting thereservoir, the bias member is operatively engaged with the handle, thehandle is operatively engaged with the plunger head, and the handle ismoved relative to the latitudinal dimension of the housing portion.

In various embodiments, the system may further include a latch forsupporting the handle when the latch is in a first position, and forreleasing the handle to allow the handle to move when the latch is movedto a second position. The bias member may be biased toward an expandedposition and held compressed by the handle in a case where the latch isin the first position and the latch is supporting the handle. The biasmember may push on the handle so as to move the handle in a case wherethe latch is moved to the second position to release the handle. Thebias member may comprise a spring.

In various embodiments, the system may include a plunger arm having afirst end and a second end. The first end of the plunger arm may beconnectable to the plunger head. The second end of the plunger arm maybe connectable to the handle. In some embodiments, the bias member maybe operatively connected between the housing portion and the handle. Inother embodiments, the bias member may be operatively connected betweenthe reservoir and the handle.

A method for transferring fluidic media in accordance with an embodimentof the present invention may include, but is not limited to, (i)providing a housing portion having a latitudinal dimension, the housingportion for supporting a reservoir connectable to a transfer guard forproviding a fluid path from a vial to the reservoir, (ii) locating abias member operatively engagable with a handle that is operativelyengagable to a plunger head positioned in a reservoir, the bias memberfor moving the handle relative to the latitudinal dimension of thehousing portion, and (iii) configuring the housing portion and the biasmember such that fluidic media is transferred from the vial to thereservoir in a case where the housing portion is supporting thereservoir, the bias member is operatively engaged with the handle, thehandle is operatively engaged with the plunger head, and the handle ismoved relative to the latitudinal dimension of the housing portion.

A system for automated pressure equalization may include, but is notlimited to, a transfer guard and a bias member. The transfer guard mayinclude a first needle and a second needle. The first needle may have afluid path for transferring fluidic media from an interior volume of avial to an interior volume of a reservoir. The second needle may have afluid path for communicating between atmosphere and the interior volumeof the vial. The bias member may be connected between an end of thereservoir and a plunger head positioned in the reservoir. The biasmember may be for providing a retaining force behind the plunger head asthe plunger head is moved within the reservoir to transfer fluidic mediafrom the interior volume of the vial to the interior volume of thereservoir. The bias member and the transfer guard may be configured toequalize pressure relative to atmosphere in the interior volume of thevial in a case where the second needle communicates between atmosphereand the interior volume of the vial and the plunger head is moved withinthe reservoir to transfer fluidic media from the interior volume of thevial to the interior volume of the reservoir.

In various embodiments, the system may include a membrane located in thefluid path of the second needle. The membrane may be for substantiallypreventing addition of water vapor through the second needle to theinterior volume of the vial. The membrane may comprise one of ahydrophobic membrane and a hydrophilic membrane. In some embodiments,the system may include a filter located in the fluid path of the firstneedle. The filter may be for degassing fluidic media transferred fromthe interior volume of the vial to the interior volume of the reservoir.The filter may comprise one of a hydrophobic filter and a hydrophilicfilter. In some embodiments, the bias member may comprise a spring.

A method for automated pressure equalization in accordance with anembodiment of the present invention may include, but is not limited to,(i) providing a transfer guard, said providing may include locating afirst needle having a fluid path for transferring fluidic media from aninterior volume of a vial to an interior volume of a reservoir, andlocating a second needle having a fluid path for communicating betweenatmosphere and the interior volume of the vial, (ii) locating a biasmember connected between an end of the reservoir and a plunger headpositioned in the reservoir, the bias member for providing a retainingforce behind the plunger head as the plunger head is moved within thereservoir to transfer fluidic media from the interior volume of the vialto the interior volume of the reservoir, and (iii) configuring the biasmember and the transfer guard to equalize pressure relative toatmosphere in the interior volume of the vial in a case where the secondneedle communicates between atmosphere and the interior volume of thevial, and the plunger head is moved within the reservoir to transferfluidic media from the interior volume of the vial to the interiorvolume of the reservoir.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 7 illustrates a system for transferring fluidic media in accordancewith an embodiment of the present invention;

FIG. 8 illustrates a system for transferring fluidic media in accordancewith an embodiment of the present invention;

FIG. 9 illustrates a system for transferring fluidic media in accordancewith an embodiment of the present invention;

FIG. 10 illustrates a cross-sectional view of a transfer guard, a vial,and a reservoir for use with a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 11 illustrates a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 12 illustrates a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 13 illustrates a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 14 illustrates a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 15 illustrates a cross-sectional view of a transfer guard, a vial,and a reservoir for use with a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 16 illustrates a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 17 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 18 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 19 illustrates a cross-sectional view of a transfer guard, a vial,and a reservoir for use with a system for transferring fluidic media inaccordance with an embodiment of the present invention;

FIG. 20 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 21 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 22 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 23 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 24 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 25 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 26 illustrates a cross-sectional view of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 27 illustrates a cross-sectional view of a vial for use with asystem for transferring fluidic media in accordance with an embodimentof the present invention;

FIG. 28 illustrates a cross-sectional view of a transfer guard for usewith a system for transferring fluidic media in accordance with anembodiment of the present invention; and

FIG. 29 illustrates a cross-sectional view of a reservoir for use with asystem for transferring fluidic media in accordance with an embodimentof the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10includes a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. The locations at which the delivery device 12 and thesensing device 14 are secured to the body 5 of the user-patient 7 inFIG. 1 are provided only as representative, non-limiting, examples.

The system 10, delivery device 12, sensing device 14, CCD 16 andcomputer 18 may be similar to those described in the following U.S.Patent Applications that were assigned to the assignee of the presentinvention, however, with a reservoir and plunger configuration such asdescribed herein with reference to FIGS. 7-8C, where each of followingpatent applications is incorporated herein by reference in its entirety:(i) U.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005,“Infusion Device And Method With Disposable Portion”; (ii) U.S. patentapplication Ser. No. 11/515,225, filed Sep. 1, 2006, “Infusion MediumDelivery Device And Method With Drive Device For Driving Plunger InReservoir”; (iii) U.S. patent application Ser. No. 11/588,875, filedOct. 27, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (iv) U.S. patent application Ser. No.11/588,832, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (v) U.S.patent application Ser. No. 11/588,847, filed Oct. 27, 2006, “InfusionMedium Delivery Device And Method With Compressible Or Curved ReservoirOr Conduit”; (vi) U.S. patent application Ser. No. 11/589,323, filedOct. 27, 2006, “Infusion Pumps And Methods And Delivery Devices AndMethods With Same”; (vii) U.S. patent application Ser. No. 11/602,173,filed Nov. 20, 2006, “Systems And Methods Allowing For Reservoir FillingAnd Infusion Medium Delivery”; (viii) U.S. patent application Ser. No.11/602,052, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (ix) U.S. patentapplication Ser. No. 11/602,428, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(x) U.S. patent application Ser. No. 11/602,113, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (xi) U.S. patent application Ser. No. 11/604,171, filed Nov.22, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (xii) U.S. patent application Ser.No. 11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery DeviceAnd Method With Drive Device For Driving Plunger In Reservoir”; (xiii)U.S. patent application Ser. No. 11/606,703, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;(xiv) U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; and (xix) U.S. patent application Ser. No. 11/759,725, filedJun. 7, 2007, “Infusion Medium Delivery Device And Method With DriveDevice For Driving Plunger In Reservoir”. In other embodiments, thesystem 10, delivery device 12, sensing device 14, CCD 16, and computer18 may have other suitable configurations.

The delivery device 12 is configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic mediaincludes a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media includes a medicine or a drug for treating a disease or amedical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediaincludes a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 includes a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7. In variousembodiments, the sensing device 14 may be secured to the body 5 of theuser-patient 7 or embedded in the body 5 of the user-patient 7 at alocation that is remote from the location at which the delivery device12 is secured to the body 5 of the user-patient 7. In various otherembodiments, the sensing device 14 may be incorporated within thedelivery device 12.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In other embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. Also, in various embodiments,the delivery device 12 and/or the sensing device 14 may be configured totransmit data to the CCD 16 and/or the computer 18 for display orprocessing of the data by the CCD 16 and/or the computer 18.

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same”, all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention includes a disposable housing 20, adurable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 supports the reservoirsystem 40 and has a bottom surface (facing downward and into the page inFIG. 2) that is configured to secure to the body of a user-patient. Anadhesive may be employed at an interface between the bottom surface ofthe disposable housing 20 and the skin of a user-patient, so as toadhere the disposable housing 20 to the skin of the user-patient. Invarious embodiments, the adhesive may be provided on the bottom surfaceof the disposable housing 20, with a peelable cover layer covering theadhesive material. In this manner, the cover layer may be peeled off toexpose the adhesive material, and the adhesive side of the disposablehousing 20 may be placed against the user-patient, for example againstthe skin of the user-patient. Thus in some embodiments, the deliverydevice 12 may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12 may include, but is not limited to,the MiniMed Paradigm 522 Insulin Pump, MiniMed Paradigm 722 InsulinPump, MiniMed Paradigm 515 Insulin Pump, MiniMed Paradigm 715 InsulinPump, MiniMed Paradigm 512R Insulin Pump, MiniMed Paradigm 712R InsulinPump, MiniMed 508 Insulin Pump, MiniMed 508R Insulin Pump, and any otherderivatives thereof.

The reservoir system 40 is configured for containing or holding fluidicmedia, such as, but not limited to insulin. In various embodiments, thereservoir system 40 includes a hollow interior volume for receivingfluidic media, such as, but not limited to, a cylinder-shaped volume, atubular-shaped volume, or the like. In some embodiments, the reservoirsystem 40 may be provided as a cartridge or canister for containingfluidic media. In various embodiments, the reservoir system 40 is ableto be refilled with fluidic media. In further embodiments, the reservoirsystem 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 includes a port 41 forallowing fluidic media to flow into and/or flow out of the interiorvolume of the reservoir system 40. In some embodiments, the infusionpath 50 includes a connector 56, a tube 54, and a needle apparatus 52.The connector 56 of the infusion path 50 may be connectable to the port41 of the reservoir system 40. In various embodiments, the disposablehousing 20 is configured with an opening near the port 41 of thereservoir system 40 for allowing the connector 56 of the infusion path50 to be selectively connected to and disconnected from the port 41 ofthe reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 iscovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. Also, in variousembodiments, the connector 56 of the infusion path 50 includes a needlefor piercing the septum covering the port 41 of the reservoir system 40so as to allow fluidic media to flow out of the interior volume of thereservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector”, which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 includes a needle that is able topuncture the skin of a user-patient. Also, in various embodiments, thetube 54 connects the connector 56 with the needle apparatus 52 and ishollow, such that the infusion path 50 is able to provide a path toallow for the delivery of fluidic media from the reservoir system 40 tothe body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures, that allow the two parts to easily connect together, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20, so as toprovide a seal against water entering between the durable housing 30 andthe disposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2), including a motor and a drive devicelinkage portion, for applying a force to fluidic media within thereservoir system 40 to force fluidic media out of the reservoir system40 and into an infusion path, such as the infusion path 50, for deliveryto a user-patient. For example, in some embodiments, an electricallydriven motor may be mounted within the durable housing 30 withappropriate linkage for operatively coupling the motor to a plunger arm(not shown in FIG. 2) connected to a plunger head (not shown in FIG. 2)that is within the reservoir system 40 and to drive the plunger head ina direction to force fluidic media out of the port 41 of the reservoirsystem 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection so as to move the plunger arm and the plunger head to causefluid to be drawn into the reservoir system 40 from a patient. The motormay be arranged within the durable housing 30 and the reservoir system40 may be correspondingly arranged on the disposable housing 20, suchthat the operable engagement of the motor with the plunger head, throughthe appropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same”, which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. Also, a flexibledisposable housing 20 may result in an increase in site options on thebody of the user-patient at which the disposable housing 20 may besecured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 16 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set”, which is incorporated herein by referencein its entirety. In the illustrated example of FIG. 2, the sensor 15 isan external sensor having a disposable needle pad that includes a needlefor piercing the skin of the user-patient and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user-patient. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user-patientat a site remote from the location at which the delivery device 12 issecured to the user-patient.

While the embodiment shown in FIG. 2 includes a sensor 15 connected bythe connection element 16 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 is configured to be secured tothe body of a user-patient. The reservoir retaining portion 24 of thedisposable housing 20 is configured to house the reservoir system 40.The reservoir retaining portion 24 of the disposable housing 20 may beconfigured to have an opening to allow for the port 41 of the reservoirsystem 40 to be accessed from outside of the reservoir retaining portion24 while the reservoir system 40 is housed in the reservoir retainingportion 24. The durable housing 30 may be configured to be attachable toand detachable from the base 21 of the disposable housing 20. Thedelivery device 12 in the embodiment illustrated in FIG. 3 includes aplunger arm 60 that is connected to or that is connectable to a plungerhead (not shown in FIG. 3) within the reservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed, leaving the hollow cannula in place, with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40, to convey pumped infusion media from thereservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 includes thedurable housing 30, and a drive device 80. The drive device 80 includesa motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). Also, in various embodiments, the durable housing 30 isconfigured with an opening 32 for receiving a plunger arm 60 (refer toFIG. 3). Also, in various embodiments, the durable housing 30 mayinclude one or more connection members 34, such as tabs, insertionholes, or the like, for connecting with the base 21 of the disposablehousing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 includes the base 21 and the reservoir retainingportion 24. In various embodiments, the base 21 includes a top surface23 having one or more connection members 26, such as tabs, grooves, orthe like, for allowing connections with the one or more connectionmembers 34 of embodiments of the durable housing 30 (refer to FIG. 5B).

In various embodiments, the reservoir system 40 is housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 is configured to hold fluidic media. Also, invarious embodiments, the plunger head 70 is disposed at least partiallywithin the reservoir system 40 and is moveable within the reservoirsystem 40 to allow fluidic media to fill into the reservoir system 40and to force fluidic media out of the reservoir system 40. In someembodiments, the plunger arm 60 is connected to or is connectable to theplunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 extends tooutside of the reservoir retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 has a mating portion formating with the drive device linkage portion 82 of the drive device 80(refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

When the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path, so as to deliver fluidic media to the bodyof the user-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, a user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. Also, in various embodiments, the reservoirsystem 40 may be replaced with a new reservoir (not shown), while thedisposable housing 20 may be re-used with the new reservoir. In suchembodiments, the new reservoir may be inserted into the disposableportion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 includes reservoir status circuitry (not shown), andthe reservoir system 40 includes reservoir circuitry (not shown). Invarious embodiments, the reservoir circuitry stores information such as,but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 includes the reservoir status circuitry (notshown), and the reservoir status circuitry is configured to read datafrom the reservoir circuitry when the reservoir system 40 is insertedinto the disposable portion 9.

In various embodiments, the reservoir status circuitry is furtherconfigured to store data to the reservoir circuitry after at least someof the contents of the reservoir system 40 have been transferred out ofthe reservoir system 40, so as to update information in the reservoircircuitry related to an amount of contents still remaining in thereservoir system 40. In some embodiments, the reservoir status circuitryis configured to store data to the reservoir circuitry, so as to updateinformation in the reservoir circuitry related to an amount of contentsstill remaining in the reservoir system 40, when the reservoir system 40is inserted into the disposable portion 9. In some embodiments, thedelivery device 12 includes the reservoir status circuitry (not shown)and the reservoir system 40 includes the reservoir circuitry (notshown), and the reservoir status circuitry selectively inhibits use ofthe delivery device 12 or selectively provides a warning signal based oninformation read by the reservoir status circuitry from the reservoircircuitry.

FIGS. 7-10 illustrate a system 100 for transferring fluidic media inaccordance with an embodiment of the present invention. The system 100may include, but is not limited to, a first housing portion 102, asecond housing portion 122, a vial 140, a reservoir 180, a plunger head190, a plunger arm 194, a handle 196, and a transfer guard 160. Thefirst housing portion 102 and the second housing portion 122 may beconfigured such that the second housing portion 122 is moveable relativeto a latitudinal dimension of the first housing portion 102. Forexample, the first housing portion 102 and the second housing portion122 may be slideably connected such that the second housing portion 122may slide into the first housing portion 102 when a user pushes thesecond housing portion 122 into the first housing portion 102.

The second housing portion 122 may have a portion 125 substantiallyextending into the first housing portion 102. The portion 125 of thesecond housing portion 122 may have a recess 127 located on a distal endof the portion 125 of the second housing portion 122. The recess 127 maybe for receiving the handle 196 when the transfer guard 160 is installedon the first housing portion 102. The handle 196 and the recess 127 maybe configured such that the handle 196 is able to fit within or snaptogether with the recess 127 to fit the handle 196 within the recess127. The system 100 may include a base 104 located on a bottom surfaceof the first housing portion 102 for standing the system 100 verticallyon a suitable surface, such as a table top, countertop, or the like. Insome embodiments, the base 104 may have an adhesive bottom 106 forattaching the system 100 to the suitable surface. In some embodiments,the base 104 may include a friction pad (not shown), which may be madeof rubber, or the like located on the bottom surface of the base 104 toprevent the system 100 from slipping during use of the system 100.

The vial 140 may include a septum 144 located at a port 142 of the vial140. The vial 140 may be for containing fluidic media. The reservoir 180may have an interior volume 185 for containing fluidic media. Theplunger head 190 may be located within the reservoir 180 and may bemoveable within the reservoir 180 to expand or contract the interiorvolume 185 of the reservoir 180. The plunger head 190 may be connectedto the plunger arm 194. The handle 196 may be connected to an end of theplunger arm 194 opposite from the end connected to the plunger head 190.The reservoir 180 may include a septum 184 located at a port 182 of thereservoir 180. The plunger head 190 may include at least one seal member199, such as an o-ring, or the like to facilitate movement within thereservoir 180 and/or to substantially prevent fluidic media from flowingbetween the plunger head 190 and the reservoir 180.

The transfer guard 160 may include a needle 165 for providing a fluidpath from an interior volume 145 of the vial 140 to the interior volume185 of the reservoir 180. The transfer guard 160 may be configured suchthat when the vial 140 is attached to the transfer guard 160, the needle165 pierces the septum 144 of the vial 140. The transfer guard 160 maybe further configured such that when the reservoir 180 is attached tothe transfer guard 160, the needle 165 pierces the septum 184 of thereservoir 180. Thus, the transfer guard 160 may allow for establishingthe fluid path from the vial 140 to the reservoir 180 through the needle165.

In some embodiments, the transfer guard 160 may include a second needle169. The second needle 169 may be able to pierce the septum 144 of thevial 140 when the vial 140 is connected to the transfer guard 160. Anend of the second needle 169 may be located within a headspace 147 ofthe vial 140 above fluidic media within the interior volume 145 of thevial 140 in a case where the transfer guard 160 is connected to the vial140. In other embodiments, the end of the second needle 169 may be incontact with fluidic media within the interior volume 145 of the vial140 in a case where the transfer guard 160 is connected to the vial 140.Another end of the second needle 169 may be connected to a check valve167, such as a one-way valve, or the like. The check valve 167 may allowair to enter the interior volume 145 of the vial 140 through the secondneedle 169. In some embodiments, the check valve 167 may substantiallyprevent liquid from coming out of the vial 140 through the second needle169 and/or the check valve 167. In various embodiments, the secondneedle 169 may allow for venting the headspace 147 or the interiorvolume 145 of the vial 140 to atmosphere to facilitate the transfer offluidic media from the vial 140 to the reservoir 180.

The transfer guard 160 may have a first end 150 for supporting the vial140. The port 142 of the vial 140 may be insertable into the first end150 of the transfer guard 160. As described above, the septum 144 of thevial 140 may be pierced by the needle 165 of the transfer guard 160 whenthe vial 140 is inserted into the first end 150 of the transfer guard160. The first end 150 of the transfer guard 160 may include a tab 152for securing the vial 140 within the first end 150 of the transfer guard160 once the vial 140 is inserted in the first end 150 of the transferguard 160. The first end 150 of the transfer guard 160 may be configuredto include multiple tabs 152 or one or more annular ribs for example, tosecure the vial 140 in the first end 150 of the transfer guard 160.

The transfer guard 160 may have a second end 170 for supporting thereservoir 180. The port 182 of the reservoir 180 may be insertable intothe second end 170 of the transfer guard 160. The septum 184 of thereservoir 180 may be pierced by the needle 165 of the transfer guard 160when the reservoir 180 is inserted into the second end 170 of thetransfer guard 160.

In some embodiments, as shown in FIGS. 10 and 27-29, the second end 170of the transfer guard 160 may include depressions or apertures 176located within the second end 170 of the transfer guard 160. The port182 of the reservoir 180 may include one or more tabs 186 for insertinginto the apertures 176 located in the second end 170 of the transferguard 160. The port 182 of the reservoir 180 may further include asecond tab 188 attached to each of the tabs 186. The reservoir 180 andport 182 may be configured to be rotatable, at least partially, aboutthe second end 170 of the transfer guard 160. The second end 170 of thetransfer guard 160 may further include one or more depressions 178 forreceiving the second tabs 188 when the reservoir 180 and port 182 arerotated to secure the reservoir 180 to the transfer guard 160. As aresult, the port 182 of the reservoir 180 may be inserted into thesecond end 170 of the transfer guard 160 so that the tabs 186 fit intothe apertures 176 and then rotated slightly until the second tabs 188fit into place within the depressions 178 to lock the reservoir 180 intothe second end 170 of the transfer guard 160.

In some embodiments, the first end 150 and the vial 140 may beconfigured in the same manner as described above so that the tabs 186fit into the apertures 176 and then rotate slightly until the secondtabs 188 fit into place within the depressions 178. In some embodiments,the second end 170 of the transfer guard 160 may be configured toinclude a tab 152 for securing the reservoir 180 within the second end170 of the transfer guard 160 similar to what was described above withrespect to the first end 150 of the transfer guard 160.

Referring back to FIGS. 7-10, once the vial 140 and the reservoir 180have been inserted in the first end 150 and the second end 170 of thetransfer guard 160 respectively, the transfer guard 160 may be ready tobe installed to the first housing portion 102. For example, in someembodiments, the first housing portion 102 may include a mating piece105 for connecting the transfer guard 160 to the first housing portion102. The transfer guard 160 may include one or more apertures 163. Themating piece 105 of the first housing portion 102 may be insertablewithin the one or more apertures 163 to connect the transfer guard 160to the first housing portion 102. The handle 196 may be fitted withinthe recess 127 after the transfer guard 160 is affixed to the firsthousing portion 102. Alternatively, the handle 196 may be fitted withinthe recess 127 before or concurrently with the transfer guard 160 beingaffixed to the first housing portion 102. In other embodiments, at leastone of the reservoir 180 and the vial 140 may be connected to thetransfer guard 160 after the transfer guard 160 has been installed tothe first housing portion 102. In various embodiments, the transferguard 160 may be attachable to the first housing portion 102 by othermeans, such as, but not limited to, screwing the transfer guard 160 tothe first housing portion 102, or the like.

In some embodiments, the plunger arm 194 and the handle 196 may beconnected to the portion 125 of the second housing portion 122 andconnected to the plunger head 190 when the transfer guard 160 isinstalled to the first housing portion 102. For example, the plunger arm194 may have a threaded end (not shown) opposite from the handle 196 forengaging a threaded recess 192 or portion within the plunger head 190.The reservoir 180 or the plunger head 190 could then be rotated toengage the plunger head 190 with the threaded end (not shown) of theplunger arm 194.

In some embodiments, the first housing portion 102 and the secondhousing portion 122 may be connected to doors 110 a, 110 b,respectively. For example, the doors 110 a, 110 b may be pivotallyconnected to the first housing portion 102 and the second housingportion 122 with hinges 112. The doors 110 a, 110 b may be held closedagainst the first housing portion 102 and the second housing portion 122with clasps 116. The system 100 may initially have both doors 110 a, 110b closed. The doors 110 a, 110 b may be opened by the user. Once thedoors 110 a, 110 b are open, the transfer guard 160 along with the vial140 and the reservoir 180 may be connected to the first housing portion102 by way of the mating piece 105 as shown in FIG. 7, and/or asdescribed above. The handle 196 may be fitted into the recess 127 of thesecond housing portion 122 when the transfer guard 160 along with thevial 140 and the reservoir 180 are connected to the first housingportion 102. Thereafter, one or both of the doors 110 a, 110 b may beclosed so that the user can use the system 100, as shown in FIG. 8.

Referring to FIGS. 7-10, the system 100 may allow for simplifying afilling process of the reservoir 180 with fluidic media from the vial140. The user may push the second housing portion 122 against the firsthousing portion 102. For example, the user may push on a top surface 126of the second housing portion 122 against the first housing portion 102or grip the second housing portion 122 and door 110 b and advance thesecond housing portion 122 and the door 110 b toward the first housingportion 102. This may cause the portion 125 of the second housingportion 122 and the recess 127 of the second housing portion 122 toslide or otherwise move further along the first housing portion 102toward the base 104 of the first housing portion 102. As a result, thehandle 196 fitted within the recess 127 may be pulled away from thereservoir 180. As the handle 196 moves away from the reservoir 180, theattached plunger arm 194 and plunger head 190 may be moved within thereservoir 180 to increase the interior volume 185 of the reservoir 180.The movement of the plunger head 190 may draw fluidic media within thevial 140 through the transfer guard 160, for example through the needle165, to the interior volume 185 of the reservoir 180, thus filling thereservoir 180. In some embodiments, the plunger head 190 may besubstantially advanced within the reservoir 180 toward the port 182 ofthe reservoir 180 before starting the filling process of the reservoir180.

The system 100 may be used to fill the interior volume 185 of thereservoir 180, or a portion thereof. The system 100 may be configuredsuch that the interior volume 185 of the reservoir 180 is completelyfilled or sufficiently filled when the second housing portion 122 ispushed completely into the first housing portion 102.

Once the user has finished using the system 100 during the fillingprocess, for example once the interior volume 185 of the reservoir 180is sufficiently filled, one or both of the doors 110 a, 110 b may beopened to remove the transfer guard 160 along with the reservoir 180 andvial 140. Alternatively, the user may remove one or more of thosecomponents, such as only the reservoir 180, while leaving the othercomponents in the system 100 for future use.

In some embodiments, the system 100 may include textured areas 118 orthe like on one or more of the first housing portion 102, the secondhousing portion 122, and the doors 110 a, 110 b. The textured areas 118may allow for increased handling or gripping of the system 100. Thetextured areas 118 may be, for example, a series of annular ribs thatsurround the system 100 or a portion thereof as exemplified in FIGS.7-9.

FIGS. 11-16 illustrate a system 200 for transferring fluidic media and aportion thereof in accordance with an embodiment of the presentinvention. The system 200 may include, but is not limited to, a firsthousing portion 202, a second housing portion 222, a vial 240, areservoir 280, a plunger head 290, a plunger arm 294, a handle 296, anda transfer guard 260. The first housing portion 202 and the secondhousing portion 222 may be configured such that the second housingportion 222 is moveable relative to a latitudinal dimension of the firsthousing portion 202. For example, the first housing portion 202 and thesecond housing portion 222 may be slideably connected such that thesecond housing portion 222 may slide over the first housing portion 202when a user pushes the second housing portion 222 into the first housingportion 202.

The second housing portion 222 may be disposed around the first housingportion 202 to at least substantially envelop an outer surface 202 a andan inner surface 202 b of the first housing portion 202. The secondhousing portion 222 may have a portion 225 located near the innersurface 202 b. The portion 225 of the second housing portion 222 mayhave a recess 227 located on a distal end of the portion 225 of thesecond housing portion 222 for receiving the handle 296 when thetransfer guard 260 is installed to the first housing portion 202. Thehandle 296 and the recess 227 may be configured such that the handle 296is able to fit within or snap together within the recess 227 to fit thehandle 296 in the recess 227. The system 200 may include a base 204located on a bottom surface of the first housing portion 202 forstanding the system 200 vertically on a suitable surface, such as atable top, countertop, or the like. In some embodiments, the base 204may have an adhesive bottom 206 for attaching the system 200 to thesuitable surface. In some embodiments, the base 204 may include afriction pad (not shown), which may be made of rubber, or the likelocated on the bottom surface of the base 204 to prevent the system 200from slipping during use of the system 100.

The vial 240 may include a septum 244 located at a port 242 of the vial240, and the vial 240 may be for containing fluidic media. The reservoir280 may have an interior volume 285 for containing fluidic media. Theplunger head 290 may be located within the reservoir 280 and may bemoveable within the reservoir 280 to expand or contract the interiorvolume 285 of the reservoir 280. The plunger head 290 may be connectedto the plunger arm 294. The handle 296 may be connected to an end of theplunger arm 294 opposite from the end connected to the plunger head 290.The reservoir 280 may include a septum 284 located at a port 282 of thereservoir 280. The plunger head 290 may include at least one seal member299, such as an o-ring, or the like to facilitate movement within thereservoir 280 and/or to substantially prevent fluidic media from flowingbetween the plunger head 290 and the reservoir 280.

The transfer guard 260 may include a needle 265 for providing a fluidpath from an interior volume 245 of the vial 240 to the interior volume285 of the reservoir 280. The transfer guard 260 may be configured suchthat when the vial 240 is attached to the transfer guard 260, the needle265 pierces the septum 244 of the vial 240. The transfer guard 260 maybe further configured such that when the reservoir 280 is attached tothe transfer guard 260, the needle 265 pierces the septum 284 of thereservoir 280. Thus, the transfer guard 260 may allow for establishingthe fluid path from the vial 240 to the reservoir 280 through the needle265.

In some embodiments, the transfer guard 260 may include a second needle269. The second needle 269 may be able to pierce the septum 244 of thevial 240 when the vial 240 is connected to the transfer guard 260. Anend of the second needle 269 may be located within a headspace 247 ofthe vial 240 above fluidic media within the interior volume 245 of thevial 240 in a case where the transfer guard 260 is connected to the vial240. In other embodiments, the end of the second needle may be incontact with fluidic media within the interior volume 245 of the vial240 in a case where the transfer guard 260 is connected to the vial 240.Another end of the second needle 269 may be connected to a check valve267, such as a one-way valve, or the like. The check valve 267 may allowair to enter the interior volume 245 of the vial 240 through the secondneedle 269. In some embodiments, the check valve 267 may substantiallyprevent liquid from coming out of the vial 240 through the second needle269 and/or the check valve 267. In various embodiments, the secondneedle 269 may allow for venting the headspace 247 or the interiorvolume 245 of the vial 240 to atmosphere to facilitate the transfer offluidic media from the vial 240 to the reservoir 280.

The transfer guard 260 may have a first end 250 for supporting the vial240. The port 242 of the vial 240 may be insertable into the first end250 of the transfer guard 260. As mentioned, the septum 244 of the vial240 may be pierced by the needle 265 of the transfer guard 260 when thevial 240 is inserted into the first end 250 of the transfer guard 260.The first end 250 of the transfer guard 260 may include a tab 252 forsecuring the vial 240 within the first end 250 of the transfer guard 260once the vial 240 is inserted in the first end 250 of the transfer guard260. The first end 250 of the transfer guard 260 may be configured toinclude multiple tabs 252 or one or more annular ribs for example, tosecure the vial 240 within the first end 250 of the transfer guard 260.

The transfer guard 260 may have a second end 270 for supporting thereservoir 280. The port 282 of the reservoir 280 may be insertable intothe second end 270 of the transfer guard 260. The septum 284 of thereservoir 280 may be pierced by the needle 265 of the transfer guard 260when the reservoir 280 is inserted into the second end 270 of thetransfer guard 260.

In some embodiments, the second end 270 of the transfer guard 260 mayinclude depressions or apertures (such as 176 in FIG. 28) located withinthe second end 270 of the transfer guard 260. The port 282 of thereservoir 280 may include one or more tabs (such as 186 in FIG. 29) forinserting into the apertures (176 in FIG. 28) located in the second end270 of the transfer guard 260. The port 282 of the reservoir 280 mayfurther include a second tab (such as 188 in FIG. 29) attached to eachof the tabs (186 in FIG. 29). The reservoir 280 and port 282 may beconfigured to be rotateable, at least partially, about the second end270 of the transfer guard 260. The second end 270 of the transfer guard260 may further include one or more depressions (such as 178 in FIG. 28)for receiving the second tabs (188 in FIG. 29) when the reservoir 280and port 282 are rotated to secure the reservoir 280 to the transferguard 260. As a result, the port 282 of the reservoir 280 may beinserted into the second end 270 of the transfer guard 260 so that thetabs (186 in FIG. 29) fit into the apertures (176 in FIG. 28) and thenrotated slightly until the second tabs (188 in FIG. 29) fit into placewithin the depressions (178 in FIG. 28) to lock the reservoir 280 intothe second end 270 of the transfer guard 260.

In some embodiments, the first end 250 of the transfer guard 260 and thevial 240 may be configured in the same manner as described above so thatthe tabs (186 in FIG. 29) fit into the apertures (176 in FIG. 28) andthen rotate slightly until the second tabs (188 in FIG. 29) fit intoplace within the depressions (178 in FIG. 28). In some embodiments, thesecond end 270 of the transfer guard 260 may be configured to include atab 252 for securing the reservoir 280 within the second end 270 of thetransfer guard 260 similar to what was described above with respect tothe first end 250 of the transfer guard 260.

Once the vial 240 and the reservoir 280 have been inserted in the firstend 250 and the second end 270 of the transfer guard 260 respectively,the transfer guard 260 may be ready to be installed to the first housingportion 202. For example, in some embodiments, the first housing portion202 may include a mating piece 205 for connecting the transfer guard 260to the first housing portion 202. The transfer guard 260 may include oneor more apertures 263. The mating piece 205 of the first housing portion202 may be insertable within the one or more apertures 263 to connectthe transfer guard 260 to the first housing portion 202. The handle 296may be fitted within the recess 227 after the transfer guard 260 isaffixed to the first housing portion 202. Alternatively, the handle 296may be fitted within the recess 227 before or concurrently with thetransfer guard 260 being affixed to the first housing portion 202. Inother embodiments, at least one of the reservoir 280 and the vial 240may be connected to the transfer guard 260 after or before the transferguard 260 has been installed to the first housing portion 202. Invarious embodiments, the transfer guard 260 may be attachable to thefirst housing portion 202 by other means, such as, but not limited to,screwing the transfer guard 260 to the first housing portion 202, or thelike.

In some embodiments, the plunger arm 294 and the handle 296 may beconnected to the portion 225 of the second housing portion 222 andconnected to the plunger head 290 when the transfer guard 260 isinstalled to the first housing portion 202. For example, the plunger arm294 may have a threaded end (not shown) opposite from the handle 296 forengaging a threaded recess 292 or portion within the plunger head 290.The reservoir 280 or the plunger head 290 could then be rotated toengage the plunger head 290 with the threaded end (not shown) of theplunger arm 294.

In some embodiments, the second housing portion 222 may be connected toa door 210. For example, the door 210 may be pivotally connected to thesecond housing portion 222 with a hinge 212. The door 210 may be heldclosed against the second housing portion 222 with a clasp 216. Thesystem 200 may initially have the door 210 closed. The door 210 may beopened by the user. Once the door 210 is open, the transfer guard 260along with the vial 240 and the reservoir 280 may be connected to thefirst housing portion 202 by way of the mating piece 205 as shown inFIGS. 11-12, and/or as described above. The handle 296 may be fittedinto the recess 227 of the second housing portion 222 when the transferguard 260 along with the vial 240 and the reservoir 280 are connected tothe first housing portion 202. Thereafter, the door 210 may be closed sothat the user can use the system 200, as shown in FIG. 13.

Referring back to FIGS. 11-16, the system 200 may allow for simplifyinga filling process of the reservoir 280 with fluidic media from the vial240. The user may push the second housing portion 222 against the firsthousing portion 202. For example, the user may grip the second housingportion 222 and door 210 and advance the second housing portion 222 andthe door 210 along the first housing portion 202 toward the base 204.This may cause the portion 225 of the second housing portion 222 and therecess 227 therein to slide or otherwise move further along the firsthousing portion 202 toward the base 204 of the first housing portion202. As a result, the handle 296 fitted within or otherwise connected tothe recess 227 may be pulled away from the reservoir 280. As the plungerarm end 296 moves away from the reservoir 280, the attached plunger arm294 and plunger head 290 may be moved within the reservoir 280 toincrease the interior volume 285 of the reservoir 280. Movement of theplunger head 290 may draw fluidic media within the vial 240 through thetransfer guard 260, for example through the needle 265, to the interiorvolume 285 of the reservoir 280, thus filling the interior volume 285 ofthe reservoir 280. In some embodiments, the plunger head 290 may besubstantially advanced within the reservoir 280 toward the port 282 ofthe reservoir 280 before starting the filling process of the reservoir280.

The system 200 may be used to fill the interior volume 285 of thereservoir 280, or a portion thereof. The system 200 may be configuredsuch that the interior volume 285 of the reservoir 280 is completelyfilled or sufficiently filled when the second housing portion 222 ispushed completely into the first housing portion 202.

Once the user has finished using the system 200 during the fillingprocess, for example once the interior volume 285 of the reservoir 280is sufficiently filled, the doors 210 may be opened to remove thetransfer guard 260 along with the reservoir 280 and vial 240.Alternatively, the user may remove one or more of those components, suchas only the reservoir 280, while leaving the other components in thesystem 200 for future use.

In some embodiments, the system 200 may include textured areas 218 orthe like on one or more of the second housing portion 222 and the door210. The textured areas 218 may allow for increased handling or grippingof the system 200. The textured areas 218 may be, for example, a seriesof annular ribs surround the system 200 or a portion thereof asexemplified in FIGS. 13 and 14.

With reference to FIGS. 11-14 and 16, in various embodiments, the system200 may include a fill volume control 230, an example of which isillustrated in FIGS. 11-14 and 16. The fill volume control 230 may befor allowing the user to select an amount of fluidic media to betransferred from the vial 240 to the reservoir 280 during the fillingprocess. The fill volume control 230 may be configured for providing theuser with a plurality of fixed positions that may be selectable by theuser. The fill volume control 230 may be further configured such thateach of the plurality of fixed positions may correspond to a fixedvolume of fluidic media to be transferred from the vial 240 to thereservoir 280 during the filling process.

In various embodiments, the fill volume control 230 may include a base232, a fill volume control handle 235, and a stop 237. The base 232 ofthe fill volume control 230 may be at least partially rotatable aboutthe first housing portion 202. In some embodiments, the base 232 of thefill volume control 230 may be connected to the base 204 of the firsthousing portion 202. In such embodiments, the base 232 of the fillvolume control 230 may be at least partially rotatable about the base204 of the first housing portion 202. The base 232 of the fill volumecontrol 230 may be rotatable to a plurality of fixed positions, whichmay correspond to a fixed volume of fluidic media to be transferred fromthe vial 240 to the reservoir 280 during the filling process.

The fill volume control handle 235 may be connected to the base 232 ofthe fill volume control 230 such that the base 232 of the fill volumecontrol 230 can be rotated when the fill volume control handle 235 ismoved. The fill volume control handle 235 may be configured to movebetween a plurality of fixed positions to rotate the base 232 of thefill volume control 230 to one of the plurality of fixed positions toselect a corresponding volume of fluidic media to be transferred fromthe vial 240 to the reservoir 280 during the filling process.

The stop 237 may be attached to the base 232 of the fill volume control230. The stop 237 may extend away from the base 232 of the fill volumecontrol 230 toward the top surface 226 of the second housing portion222. The stop 237 may be configured such that the distance between thestop 237 and the reservoir 280 corresponds to a volume of fluidic mediato be transferred from the vial 240 to the reservoir 280 during thefilling process. The stop 237 may be for preventing the second housingportion 222 from advancing toward the base 204 of the first housingportion 202 beyond a point where the stop 237 contacts the bottom of thehandle 296. Accordingly, the plunger head 290 and the handle 296 may bemoveable within the reservoir 280 until the stop 237 contacts the bottomof the handle 296. Therefore, fluidic media may be transferred from thevial 240 to the reservoir 280 until the stop 237 prevents furthermovement of the handle 296 and the plunger head 290.

In various embodiments, the stop 237 may have one or more stop surfaces,such as a first stop surface 237 a, located on an end of the stop 237extending away from the base 232 of the fill volume control 230. Thestop 237 may be configured such that the distance between the first stopsurface 237 a and the reservoir 280 corresponds to a first volume offluidic media to be transferred from the vial 240 to the reservoir 280.The first stop surface 237 a may be for preventing the second housingportion 222 from advancing toward the base 204 of the first housingportion 202 beyond a point where the first stop surface 237 a contactsthe bottom of the handle 296. Accordingly, the plunger head 290 and thehandle 296 may be moveable within the reservoir 280 until the first stopsurface 237 a contacts the bottom of the handle 296. Therefore, fluidicmedia may be transferred from the vial 240 to the reservoir 280 untilthe first stop surface 237 a prevents further movement of the handle 296and the plunger head 290.

In various embodiments, the stop 237 may include a second stop surface237 b. The stop 237 may be configured such that the second stop surface237 b may be located on an end of the stop 237 further from the base 232of the fill volume control 230 than the first stop surface 237 a. Thestop 237 may be further configured such that the distance between thesecond stop surface 237 b and the reservoir 280 corresponds to a secondvolume of fluidic media to be transferred from the vial 240 to thereservoir 280. The second stop surface 237 b may be for preventing thesecond housing portion 222 from advancing toward the base 204 of thefirst housing portion 202 beyond a point where the second stop surface237 b contacts the bottom of the handle 296. Accordingly, the plungerhead 290 and the handle 296 may be moveable within the reservoir 280until the second stop surface 237 b contacts the bottom of the handle296. Therefore, fluidic media may be transferred from the vial 240 tothe reservoir 280 until the second stop surface 237 b prevents furthermovement of the handle 296 and the plunger head 290.

In various embodiments, the stop 237 may further include additional stopsurfaces, such as a third stop surface (not shown), a fourth stopsurface (not shown), and so on. The stop 237 may be configured such thateach of the additional stop surfaces may be located on an end of thestop 237 further from the base 232 of the fill volume control 230 thanthe previous stop surface. The stop 237 may be further configured suchthat the distance between the additional stop surfaces and the reservoir280 corresponds to volumes of fluidic media to be transferred from thevial 240 to the reservoir 280 during the filling process. For example,in a case where a stop 237 has four stop surfaces, the third stopsurface (not shown) may be located further from the base 232 of the fillvolume control 230 than the second stop surface 237 b. Meanwhile, thefourth stop surface (not shown) may be located further from the base 232of the fill volume control 230 than the third stop surface (not shown).

One of the additional stop surfaces may be for preventing the secondhousing portion 222 from advancing toward the base 204 of the firsthousing portion 202 beyond a point where the one of the additional stopsurfaces contacts the bottom of the handle 296. Accordingly, the plungerhead 290 and the handle 296 may be moveable within the reservoir 280until the one of the additional stop surfaces contact the bottom of thehandle 296. Therefore, fluidic media may be transferred from the vial240 to the reservoir 280 until the one of the additional stop surfacesprevent further movement of the handle 296 and the plunger head 290. Forexample, in a case where a stop 237 has four stop surfaces, the thirdstop surface (not shown) may prevent the second housing portion 222 fromadvancing toward the base 204 of the first housing portion 202 beyondthe third stop surface (not shown) in a case where the third stopsurface (not shown) contacts the bottom of the handle 296.

In some embodiments, the fill volume control 230 may include a pluralityof stops 237. Each of the plurality of stops 237 may be of varyinglengths, such that each of the plurality of stops 237 extends varyinglengths away from the base 232 of the fill volume control 230. Each ofthe plurality of stops 237 may be configured such that the distancebetween each of the plurality of stops 237 and the reservoir 280corresponds to volumes of fluidic media to be transferred from the vial240 to the reservoir 280 during the filling process.

One of the plurality of stops 237 may be for preventing the secondhousing portion 222 from advancing toward the base 204 of the firsthousing portion 202 beyond a point where the one of the plurality ofstops 237 contacts the bottom of the handle 296. Accordingly, theplunger head 290 and the handle 296 may be moveable within the reservoir280 until the one of the plurality of stops 237 contacts the bottom ofthe handle 296. Therefore, fluidic media may be transferred from thevial 240 to the reservoir 280 until the one of the plurality of stops237 prevents further movement of the handle 296 and the plunger head290.

In some embodiments, the stop 237 of the fill volume control 230 mayhave an angled surface (not shown) angled relative to the base 232 ofthe fill volume control 230, for example angled at a 45° angle. Theangled surface (not shown) of the stop 237 may extend away from the base232 of the fill volume control 230. The distances between variouslocations on the angled surface (not shown) of the stop 237 may beconfigured such that the distance between each of the various locationsand the reservoir 280 corresponds to volumes of fluidic media to betransferred from the vial 240 to the reservoir 280 during the fillingprocess.

One of the various locations on the angled surface (not shown) of thestop 237 may be for preventing the second housing portion 222 fromadvancing toward the base 204 of the first housing portion 202 beyond apoint where the one of the various locations on the angled surface (notshown) of the stop 237 contacts the bottom of the handle 296.Accordingly, the plunger head 290 and the handle 296 may be moveablewithin the reservoir 280 until the one of the various locations on theangled surface (not shown) of the stop 237 contacts the bottom of thehandle 296. Therefore, fluidic media may be transferred from the vial240 to the reservoir 280 until the one of the various locations on theangled surface (not shown) of the stop 237 prevents further movement ofthe handle 296 and the plunger head 290.

In some embodiments, the handle 296 connected to the plunger arm 294 mayinclude an aperture 298. The stop 237 may be configured to be insertableinto the aperture 298 in a case where the stop 237 and the aperture 298are aligned prior to the filling process and the handle 296 is advancedbeyond at least a portion of the stop 237 during the filling process.While the stop 237 is aligned with the aperture 298, the stop 237 mayslide or otherwise fit into the aperture 298 to allow the handle 296 toadvance toward the base 204 of the first housing portion 202 during thefilling process.

In some embodiments, the stop 237 may be configured such that stopsurfaces (e.g., 237 a, 237 b) aligned with the aperture 298 prior to thefilling process may be insertable in the aperture 298 during the fillingprocess. Each of the stop surfaces aligned with the aperture 298 priorto the filling process may slide or otherwise fit into the aperture 298and allow the second housing portion 222, which is supporting the handle296, to advance toward the base 204 of the first housing portion 202during the filling process. Because the aperture 298 is located on thehandle 296, the handle 296 may slide along the stop 237 and the stopsurfaces that were aligned with the aperture 298 prior to the fillingprocess as the handle 296 is moved toward the base 204.

The plunger head 290 and the handle 296 may be moved to a final positionwhere either at least one of the stop surfaces not aligned with theaperture 298 prior to the filling process contacts the handle 296 or thebase 232 of the fill volume control 230 (i.e., the second housingportion 222 is advanced completely towards the base 232 of the fillvolume control 230). Accordingly, the second housing portion 222 may bemoveable to the final position. Therefore, fluidic media may betransferred from the vial 240 to the reservoir 280 until the at leastone of the stop surfaces not aligned with the aperture 298 prior to thefilling process or the base 232 of the fill volume control 230 preventsfurther movement of the handle 296 and the plunger head 290.

For example, according to an embodiment exemplified in FIGS. 11-14 and16, the fill volume control handle 235 may have three selectablepositions, such as a first position 238 a, a second position 238 b, anda third position 238 c, corresponding to three fixed volumes of fluidicmedia, such as 3 ml, 2 ml, and 1 ml, respectively, selectable by theuser to be transferred from the vial 240 to the reservoir 280 during thefilling process. The stop 237 may be further configured such that thedistance between the stop surfaces 237 a, 237 b and the reservoir 280also corresponds to the volumes of fluidic media to be transferred fromthe vial 240 to the reservoir 280 during the filling process, such as 2ml and 1 ml, respectively. While the distance between the base 232 ofthe fill volume control 230 and the reservoir 280 may correspond to 3ml.

Therefore, if the reservoir 280 is to be filled with 1 ml of fluidicmedia, the fill volume control handle 235 may be moved to the thirdposition 238 c. In the third position 238 c, the first stop surface 237a and the second stop surface 237 b are not aligned with the aperture298 of the handle 296 prior to the filling process. Thus during thefilling process, the handle 296 and the plunger head 290 are onlyadvanceable until the handle 296 contacts the second stop surface 237 b.Accordingly, because the stop 237 may be configured such that thedistance between the second stop surface 237 b and the reservoir 280corresponds to 1 ml, 1 ml of fluidic media may be transferred from thevial 240 to the reservoir 280 during the filling process.

Continuing with the previous example, if the reservoir 280 is to befilled with 2 ml of fluidic media, the fill volume control handle 235may be moved to the second position 238 b. In the second position 238 b,the second stop surface 237 b is aligned with the aperture 298 of thehandle 296 prior to the filling process, while the first stop surface237 a is not aligned with the aperture 298 of the handle 296. Thusduring the filling process, the handle 296 and the plunger head 290 areadvanceable past the second stop surface 237 b to a point where thehandle 296 contacts the first stop surface 237 a. Accordingly, becausethe stop 237 is configured such that the distance between the first stopsurface 237 a and the reservoir 280 corresponds to 2 ml, 2 ml of fluidicmedia may be transferred from the vial 240 to the reservoir 280 duringthe filling process.

Again continuing with the previous example, if the reservoir 280 is tobe filled with 3 ml of fluidic media, the fill volume control handle 235may be moved to the first position 238 a. In the first position 238 a,the first stop surface 237 a and the second stop surface 237 b arealigned with the aperture 298 of the handle 296 prior to the fillingprocess. Thus during the filling process, the handle 296 and the plungerhead 290 are advanceable past the first stop surface 237 a and thesecond stop surface 237 b to a point where the handle 296 contacts thebase 232 of the fill volume control 230. Accordingly, because the fillvolume control 230 may be configured such that the distance between thebase 232 of the fill volume control 230 and the reservoir 280corresponds to 3 ml, 3 ml of fluidic media may be transferred from thevial 240 to the reservoir 280 during the filling process.

In some embodiments, the fill volume control 230 may further includeabutments 231 a, 231 b to prevent the fill volume control handle 235from moving beyond the abutments 231 a, 231 b. Accordingly, theabutments 231 a, 231 b may allow for restricting the rotation of thebase 232 of the fill volume control 230 about the first housing portion202. The abutments 231 a, 231 b may be part of the first housing portion202. Using the previous example, the abutments 231 a , 231 b may preventthe rotation of the fill volume control handle 235 of the fill volumecontrol 230 beyond the first position 238 a and the third position 238c, respectively.

In some embodiments, the fill volume control 230 may further includeprotrusions 239 located in front and/or behind of each of the pluralityof selectable positions of the fill volume control handle 235. Theprotrusions 239 may be located on the base 204 of the first housingportion 202 or the base 232 of the fill volume control 230. Theprotrusions 239 may be for inhibiting accidental movement of the fillvolume control handle 235 beyond each set of the protrusions 239. Thefill volume control handle 235 may be moveable beyond each set of theprotrusions 239 when a sufficient force is applied to the fill volumecontrol handle 235. In some embodiments, the set of protrusions mayserve to designate each of the plurality of selectable positions for thefill volume control handle 235.

FIGS. 17-21 illustrate a system 300 for transferring fluidic media and aportion thereof in accordance with an embodiment of the presentinvention. The system 300 may include, but is not limited to, a firsthousing portion 302, a second housing portion 322, a vial 340, areservoir 380, a plunger head 390, a plunger arm 394, and a transferguard 360. The first housing portion 302 and the second housing portion322 may be configured such that the second housing portion 322 ismoveable relative to a latitudinal dimension of the first housingportion 302. For example, the first housing portion 302 and the secondhousing portion 322 may be slideably connected such that the secondhousing portion 322 may slide over the first housing portion 302 when auser pushes the second housing portion 322 into the first housingportion 302.

The second housing portion 322 may be disposed around the first housingportion 302 to envelop a portion of an outer surface 302 a and a portionof an inner surface 302 b of the first housing portion 302. An end ofthe plunger arm 394 may be connected to the first housing portion 302.Another end of the plunger arm 394 opposite from the end connected tothe first housing portion 302 may have a portion 393 for connecting withthe plunger head 390. The system 300 may include a base 304 located on abottom end of the bottom portion 302 for standing the system 300vertically on a suitable surface, such as a table top, countertop, orthe like. In some embodiments, the base 304 may have an adhesive bottom(not shown) for attaching the system 300 to the suitable surface. Insome embodiments, the base 304 may include a friction pad (not shown),which may be made of rubber, or the like located on the bottom surfaceof the base 304 to prevent the system 300 from slipping during usage ofthe system 300.

The vial 340 may include a septum 344 located at a port 342 of the vial340, and the vial 340 may be for containing fluidic media. The reservoir380 may have an interior volume 385 for containing fluidic media. Theplunger head 390 may be located within the reservoir 380 and may bemoveable within the reservoir 380 to expand or contract the interiorvolume 385 of the reservoir 380. The plunger head 390 may be connectableto the plunger arm 394. The reservoir 380 may include a septum 384located at a port 382 of the reservoir 380. The plunger head 390 mayinclude at least one seal member 399, such as an o-ring, or the like tofacilitate movement within the interior volume 385 of the reservoir 380and/or to substantially prevent fluidic media from flowing between theplunger head 390 and the reservoir 380.

The transfer guard 360 may include a needle 365 for providing a fluidpath from the interior volume 345 of the vial 340 to the interior volume385 of the reservoir 380. The transfer guard 360 may be configured suchthat when the vial 340 is attached to the transfer guard 360, the needle365 pierces the septum 344 of the vial 340. The transfer guard 360 maybe further configured such that when the reservoir 380 is attached tothe transfer guard 360, the needle 365 pierces the septum 384 of thereservoir 380. Thus, the transfer guard 360 may allow for establishingthe fluid path from the vial 340 to the reservoir 380 through the needle365.

In some embodiments, the transfer guard 360 may include a second needle369. The second needle 369 may be able to pierce the septum 344 of thevial 340 when the vial 340 is connected to the transfer guard 360. Anend of the second needle 369 may be located within a headspace 347 ofthe vial 340 above fluidic media within the interior volume 345 of thevial 340 in a case where the transfer guard 360 is connected to the vial340. In other embodiments, the end of the second needle 369 may be incontact with fluidic media within the interior volume 345 of the vial340 in a case where the transfer guard 360 is connected to the vial 340.Another end of the second needle 369 may be connected to a check valve367, such as a one-way valve, or the like. The check valve 367 may allowair to enter the interior volume 345 of the vial 340 through the secondneedle 369. In some embodiments, the check valve 367 may substantiallyprevent liquid from coming out of the vial 340 through the second needle369 and/or the check valve 367. In various embodiments, the secondneedle 369 may allow for venting the headspace 347 or the interiorvolume 345 of the vial 340 to atmosphere to facilitate the transfer offluidic media from the vial 140 to the reservoir 180.

The transfer guard 360 may have a first end 350 for supporting the vial340. The port 342 of the vial 340 may be insertable into the first end350 of the transfer guard 360. As mentioned, the septum 344 of the vial340 may be pierced by the needle 365 of the transfer guard 360 when thevial 340 is inserted into the first end 350 of the transfer guard 360.The first end 350 of the transfer guard 360 may include a tab 352 forsecuring the vial 340 within the first end 350 of the transfer guard 360once the vial 340 is inserted in the first end 350 of the transfer guard360. The first end 350 of the transfer guard 360 may be configured toinclude multiple tabs 352 or one or more annular ribs for example, tosecure the vial 340 within the first end 350 of the transfer guard 360.

The transfer guard 360 may have a second end 370 for supporting thereservoir 380. The port 382 of the reservoir 380 may be insertable intothe second end 370 of the transfer guard 360. The septum 384 of thereservoir 380 may be pierced by the needle 365 of the transfer guard 360when the reservoir 380 is inserted into the second end 370 of thetransfer guard 360.

In some embodiments, the second end 370 of the transfer guard 360 mayinclude depressions or apertures (such as 176 in FIG. 28) located withinthe second end 370 of the transfer guard 360. The port 382 of thereservoir 380 may include one or more tabs (such as 186 in FIG. 29) forinserting into the apertures (176 in FIG. 28) located in the second end370 of the transfer guard 360. The port 382 of the reservoir 380 mayfurther include a second tab (such as 188 in FIG. 29) attached to eachof the tabs (186 in FIG. 29). The reservoir 380 and port 382 may beconfigured to be rotatable, at least partially, about the second end 370of the transfer guard 360. The second end 370 of the transfer guard 360may further include one or more depressions (such as 178 in FIG. 28) forreceiving the second tabs (188 in FIG. 29) when the reservoir 380 andport 382 are rotated to secure the reservoir 380 to the transfer guard360. As a result, the port 382 of the reservoir 380 may be inserted intothe second end 370 of the transfer guard 360 so that the tabs (186 inFIG. 29) fit into the apertures (176 in FIG. 28) and then rotatedslightly until the second tabs (188 in FIG. 29) fit into place withinthe depressions (178 in FIG. 28) to lock the reservoir 280 into thesecond end 270 of the transfer guard 260.

In some embodiments, the first end 350 of the transfer guard 360 and thevial 340 may be configured in the same manner as described above so thatthe tabs (186 in FIG. 29) fit into the apertures (176 in FIG. 28) andthen rotates slightly until the second tabs (188 in FIG. 29) fit intoplace within the depressions (178 in FIG. 28). In some embodiments, thesecond end 370 of the transfer guard 360 may be configured to include atab 352 for securing the reservoir 380 within the second end 370 of thetransfer guard 360 similar to what was described above with respect tothe first end 350 of the transfer guard 360.

Once the vial 340 and the reservoir 380 have been inserted in the firstend 350 and the second end 370 of the transfer guard 360 respectively,the transfer guard 360 may be ready to be installed to the first housingportion 302. In some embodiments, the transfer guard 360 may havethreaded sides 363. The second housing portion 322 may have a threadedarea 323 for engaging the threaded sides 363 of the transfer guard 360when, for example, the transfer guard 360 is rotated into place toconnect the transfer guard 360 to the second housing portion 322. Insome embodiments, the plunger arm 394 may have a threaded tip 393. Theplunger head 390 may have a threaded recess 392 or portion for engagingthe threaded tip 393 when, for example, the reservoir 380 is rotatedinto place to connect the plunger head 390 to the plunger arm 394. Thethreaded side 363 of the transfer guard 360 and the threaded area 323 ofthe second housing portion 322 may be engaged approximately at the sametime that the threaded tip 393 of the plunger arm 394 and the threadedrecess 392 of the plunger head 390 are being engaged. As a result, onlythe transfer guard 360 may have to be rotated by the user to engage thethreaded side 363 of the transfer guard 360 to the threaded area 323 ofthe second housing portion 322 and the threaded tip 393 of the plungerarm 394 to the threaded recess 392 of the plunger head 390.Alternatively, the system 300 may be configured such that the reservoir380 or the vial 340 could be rotated by the user instead of the transferguard 360 to secure the transfer guard 360 to the second housing portion322.

In some embodiments, the second housing portion 322 may be connected toa door (not shown). For example, the door may be pivotally connected tothe second housing portion 322 with a hinge (not shown). The door (notshown) may be held closed against the second housing portion 322 with aclasp (not shown). The system 300 may initially have the door (notshown) closed. The door (not shown) may be opened by the user. Once thedoor (not shown) is open, the transfer guard 360 along with the vial 340and the reservoir 380 may be connected to the first housing portion 302as described above. Thereafter, the door (not shown) may be closed sothat the user can use the system 300.

The system 300 may allow for automating a filling process of thereservoir 380 with fluidic media from the vial 340. The system 300 mayinclude a bias member, such as a spring 307, or the like. In someembodiments, the system 300 may further include a latch (not shown).

The spring 307 may be connected between a bottom surface 322 d of thesecond housing portion 322 and a surface 302 c of the first housingportion 302. The spring 307 may be initially biased toward an expandedposition. The second housing portion 322 may be moveable along thelatitudinal dimension of the first housing portion 302 between at leasta first position and a second position. In the first position of thesecond housing portion 322, the spring 307 may be in the expandedposition. In the second position of the second housing portion 322, thespring 307 may be held compressed by the second housing portion 322. Thespring 307 and/or the second housing portion may be held in place by alatch (not shown).

The system 300 may allow for the transfer guard 360 along with thereservoir 380 and vial 340 to be connected to the second housing portion322. In addition, the system 300 may allow for filling the reservoir 380using a force applied by the spring 307 on the second housing portion322 when the latch (not shown) is released to allow the spring to pushup on the bottom surface 322 d of the second housing portion 322.According to an embodiment of the present invention, the system 300, thefirst housing portion 302 may be connected to the plunger arm 394, theplunger arm 394 may be connected to the plunger head 390, and thetransfer guard 360 and reservoir 380 may be supported by the secondhousing portion 322 such that movement of the second housing portion322, and thus the reservoir 380, away from the first housing portion302, and thus the plunger head 390, causes the reservoir 380 to moverelative to the plunger head 390 to create a vacuum that enables afilling of the reservoir 380.

The latch (not shown) may be moveable between a locked position and anunlocked position. The latch (not shown) may be for holding the spring307 compressed or for holding the second housing portion 322 against thespring 307 when in the locked position. In various embodiments, thesystem may include a button 308 for moving the latch (not shown) fromthe unlocked position to the locked position. The system may furtherinclude a second button 309 for moving the latch (not shown) from thelocked position to the unlocked position. In other embodiments, thebutton 308 may be for moving the latch (not shown) from the lockedposition to the unlocked position as well.

For example, the user could push the second housing portion 322 into thefirst housing portion 302 (i.e., move the second housing portion 322 tothe second position) and then press the button 308 to move the latch(not shown) to the locked position to keep the second housing portion322 at the second position. The transfer guard 360 along with thereservoir 380 and the vial 340 may be connected to the second housingportion 322 as described above. Once installed, the second button 309may be pressed to release the latch (not shown) allowing the spring 307to expand and thus return the second housing portion 322 to the firstposition. In returning to the first position, fluidic media may be drawninto the interior volume 385 of the reservoir 380 from the interiorvolume 345 of the vial 340 as described above.

In various embodiments, a tension of the spring 307 may be selected soas to allow for the reservoir 380 to fill at different rates when thespring 307 expands depending on the tension of the spring 307. Thus,various embodiments of the present invention allow for spring loadedautomatic filling of a reservoir, and for drawing a fluid or drug froman inverted vial into a reservoir.

The system 300 may be used to fill the interior volume 385 of thereservoir 380, or a portion thereof. The system 300 may be configuredsuch that the interior volume 385 of the reservoir 380 is completelyfilled or sufficiently filled in a case where the spring 307 forces thesecond housing portion 322 substantially away from the first housingportion 302.

Once the user has finished using the system 300 during the fillingprocess, for example once the interior volume 385 of the reservoir 380is sufficiently filled, the door (not shown) may be opened to remove thetransfer guard 360 along with the reservoir 380 and vial 340.Alternatively, the user may remove one or more of those components, suchas only the reservoir 380, while leaving the other components in thesystem 300 for future use.

In some embodiments, the system 300 may include textured areas (such as218 in FIGS. 13 and 14), or the like, on one or more of the secondhousing portion 322 and the door (not shown). The textured areas (218 inFIGS. 13 and 14) may allow for increased handling or gripping of thesystem 300. The textured areas (218 in FIGS. 13 and 14) may be, forexample, a series of annular ribs that surround the system 300 or aportion thereof as exemplified in FIGS. 13 and 14.

FIGS. 22-23 illustrate a cross-sectional view of a system 400 inaccordance with an embodiment of the present invention. The system 400may include, but is not limited to, a vial 440, a reservoir 480, aplunger head 490, a plunger arm 494, a transfer guard 460, and a housingportion 402. The vial 440 may include a septum 444. The vial 440 may befor containing fluidic media. The reservoir 480 may have an interiorvolume for containing fluidic media. The plunger head 490 may be locatedwithin the reservoir 480 and may be moveable within the reservoir 480 toexpand or contract the interior volume of the reservoir 480. The plungerhead 490 may be connected to the plunger arm 494. The reservoir 480 mayinclude a septum 484 located at a port of the reservoir 480. Thetransfer guard 460 may include a needle 465 for providing a fluid pathfrom an interior volume of the vial 440 to the interior volume of thereservoir 480. The needle 465 of the transfer guard 460 may be able topierce the septum 444 of the vial 440 and the septum 484 of thereservoir 480, so as to provide a fluid path from the vial 440 to thereservoir 480 through the needle 465. The plunger head 490 may includeat least one seal member 499, such as an o-ring, or the like tofacilitate movement within the interior volume of the reservoir 480and/or to substantially prevent fluidic media from flowing between theplunger head 490 and the reservoir 480.

The system 400 may allow for automating a filling process of thereservoir 480 with fluidic media from the vial 440. The system 400 mayinclude a bias member such as a spring 407 and a handle 496. In variousembodiments, the system 400 may further include a latch 408. In variousembodiments, the plunger arm 494 and the handle 496 may be configuredsuch that the plunger arm 494 is able to snap together with the handle496 to connect the plunger arm 494 to the handle 496. In various otherembodiments, the plunger arm 494 and the handle 496 may be configured tobe connected in other ways, such as by screwing the plunger arm 494 intothe handle 496. In some embodiments, the handle 486 may be part of theplunger arm 494, and the handle 496 may be connectable to the spring407.

The spring 407 may be connected between a top surface of the housingportion 402 and the handle 496. The spring 407 may be initially biasedtoward an expanded position, but may be held compressed by the handle496, which may be held in place by the latch 408. The system 400 mayallow for the reservoir 480 to be snapped or otherwise connected inplace within the housing portion 402. The system 400 may allow forfilling the reservoir 480 using a force applied by the spring 407 on thehandle 496 when the latch 408 is released to allow the spring 407 topush down on the handle 496. According to one embodiment of the system400, the handle 496 may be connected to the plunger arm 494, and theplunger arm 494 may be connected to the plunger head 490. In such anembodiment, movement of the handle 486 away from the reservoir 480 maycause the plunger head 490 to move within the reservoir 480 to create avacuum that enables a filling of the reservoir 480 by drawing fluid fromthe vial 440.

In various embodiments, a tension of the spring 407 may be selected soas to allow for the reservoir 480 to fill at different rates when thespring 407 expands depending on the tension of the spring 407. Thus,various embodiments of the present invention allow for spring loadedautomatic filling of a reservoir, and for drawing a fluid or drug froman inverted vial into a reservoir. In some embodiments, a lead screw(not shown) may be used in place of the spring 407 to move the plungerarm 494 for an automated filling of the reservoir 480.

FIGS. 24-25 illustrate a cross-sectional view of a system 500 inaccordance with an embodiment of the present invention. The system 500may include, but is not limited to, a reservoir 580, a plunger head 590,a plunger arm 594, a transfer guard 560, a vial 540, and a vibratingapparatus 530. The vial 540 may be for containing fluidic media. Thetransfer guard 560 may include a needle 565 for transferring fluidicmedia between the vial 540 and the reservoir 580. The vial 540 mayinclude a septum 544 pierceable by the needle 565. The reservoir 580 mayinclude a septum 584 pierceable by the needle 565. The system 500 mayinclude a handle 596 connected to the plunger arm 594. The vibratingapparatus 530 may include a holding unit 535 and a vibrator 531.

In various embodiments, the vibrating apparatus 530 may further includea power source 532. The power source 532 may comprise, for example, anelectrical plug for plugging the vibrator 531 into an electrical socket,a battery for powering the vibrator 531, or the like. In variousembodiments, the vibrator 531 is an electric vibrator, or the like.

The holding unit 535 may allow for holding the reservoir 580. In variousembodiments, the holding unit 535 may include a first holder 536 and asecond holder 537 for holding the reservoir 580. The holding unit 535may be configured such that the plunger arm 594 that is connected to theplunger head 590 located within the reservoir 580 is moveable in a casewhere the holding unit 535 is holding the reservoir 580 and thereservoir 580 is being filled with fluidic media.

The vibrator 531 may allow for vibrating the holding unit 535 such thatthe reservoir 580 is vibrated. In various embodiments, the vibrator 531may be configured to vibrate the holding unit 535 in a case where theholding unit 535 is holding the reservoir 580 and the reservoir 580 isbeing filled with fluidic media, so as to vibrate the reservoir 580 anddegas or otherwise cause air bubbles contained in fluidic media in thereservoir 580 to travel upwards within the reservoir 580. Additionally,in various embodiments, the vibrator 531 may be configured to shake theholding unit 535 sufficiently in a case where the holding unit 535 isholding the reservoir 580 and the reservoir 580 is being filled withfluidic media such that air bubbles are shaken free from fluidic mediacontained in the reservoir 580.

In various embodiments, the holding unit 535 may include the firstholder 536 and the second holder 537. The plunger arm 594 may bemoveable within a space 539 between the first holder 536 and the secondholder 537 in a case where the reservoir 580 is being held by the firstholder 536 and the second holder 537 and the reservoir 580 is beingfilled with fluidic media. In various embodiments, the first holder 536and the second holder 537 may be connected to the vibrator 531. Inaddition, in various embodiments, the space 539 may be at leastpartially between the plunger arm 594 and the vibrator 531.

In some embodiments, one or both of the first holder 536 and the secondholder 537 may be attached to the vibrator 531 with hinges or doors (notshown) or the like. The doors (not shown) may be configured to swingopen to allow for placing the reservoir 580 at least partially betweenthe first holder 536 and the second holder 537. The doors (not shown)may be further configured to swing closed and lock so that the reservoir580 is held tightly between the first holder 536 and the second holder537. Additionally, in some embodiments, the holding unit 535 may furtherinclude cushions 534 between the first holder 536 and the reservoir 580,and between the second holder 537 and the reservoir 580. In variousembodiments, the holding unit 535 may be a single member into which thereservoir 580 is inserted and held securely.

In various embodiments, the holding unit 535 may be configured suchthat, in a case where the holding unit 535 is holding the reservoir 580,fluidic media is able to be drawn into the reservoir 580 through a port582 of the reservoir 580 that is located to an opposite side of theplunger head 590 from the plunger arm 594. Additionally, in variousembodiments, the holding unit 535 may be configured such that theplunger arm 594 is moveable in a direction toward the vibrator 531 in acase where the holding unit 535 is holding the reservoir 580 and thereservoir 580 is being filled with fluidic media.

In various embodiments, the vibrating apparatus 530 may include one ormore supports 533 for supporting the holding unit 535. The one or moresupports 533 may be attached to a stand (not shown), or the like.

In various embodiments, the system 500 may include the transfer guard560. The transfer guard 560 may allow for transferring fluidic mediafrom the vial 540 to the reservoir 580 in a case where the holding unit535 is holding the reservoir 580. In some embodiments, the transferguard 560 may include an end 570 for supporting the reservoir 580. Theport 582 of the reservoir 580 may be insertable into the end 570 of thetransfer guard 560. The septum 584 of the reservoir 580 may be piercedby the needle 565 of the transfer guard 560 when the reservoir 580 isinserted into the end 570 of the transfer guard 560.

In some embodiments, the vibrating apparatus 530 may include one or morelatches 538. The one or more latches 538 may allow for preventing theplunger arm 594 from being moved when the holding unit 535 is holdingthe reservoir 580 prior to a time when the reservoir 580 is being filledwith fluidic media. As a result, the plunger head 590 that is connectedto the plunger arm 594 is not moveable within the reservoir 580 when theholding unit 535 is holding the reservoir 580 prior to the time when thereservoir 580 is being filled with fluidic media. In variousembodiments, the one or more latches 538 may clasp or otherwise holdonto one or both of the plunger arm 594 and the handle 596. In suchembodiments, the one or more latches 538 may be operable to swing open,retract, or otherwise release one or both of the plunger arm 594 and thehandle 596 to allow the plunger arm 594 to move within the space 539,such that the plunger head 590 can be moved within the reservoir 580.Thus, the reservoir 580 may be filled with fluidic media drawn from thevial 540.

The holding unit 535 may be configured such that the handle 596connected to the plunger arm 594 is moveable within the space 539between the reservoir 538 and the vibrator 531 in a case where theholding unit 535 is holding the reservoir 580 and the reservoir 580 isbeing filled with fluidic media. In some embodiments, the handle 596 maybe disconnectable from the plunger arm 594, such that the handle 596 maybe disconnected from the plunger arm 594 after the reservoir 580 hasbeen sufficiently filled with fluidic media.

In some embodiments, the handle 596 may be able to be pulled by a userwhile the vibrator 531 is vibrating the reservoir 580. In various otherembodiments, the handle 596 may be connected to a bias member (notshown), such as a spring to move the handle 596 so as to move theplunger head 590 when the one or more latches 538 are opened to releaseone or both of the plunger arm 594 and the handle 596. In someembodiments, the system may further include a motor (not shown) formoving one or both of the plunger arm 594 and the handle 596 such thatthe plunger head 590 is moveable within the reservoir 580 while theholding unit 535 is holding the reservoir 580.

According to an embodiment exemplified in FIGS. 24 and 25, during afilling process, the needle 565 of the transfer guard 560 may establisha fluid path between the vial 540 and the reservoir 580. The one or morelatches 580 may be released from the handle 596 to allow the plungerhead 590 to move to allow fluidic media to flow from the vial 540 intothe reservoir 580. While the reservoir 580 is filling with fluidicmedia, the vibrator 531 may vibrate the reservoir 580 such that airbubbles in fluidic medium contained in the reservoir 580 travel upwardstoward the port 582 of the reservoir 580. Thus, in various embodiments,the vibrator 531 may allow for shaking the reservoir 580 to degasfluidic media being filled into the reservoir 580. In variousembodiments, once the filling process has completed in the system 500,the vial 540 may be disconnected from the transfer guard 560. Air in thereservoir 580 may be subsequently pushed out of the reservoir 580, forexample, by pressing on the handle 596.

FIG. 26 illustrates a cross-sectional view of a system 600 in accordancewith an embodiment of the present invention. The system 600 may include,but is not limited to, a reservoir 680, a plunger head 690, a plungerarm 694, a handle 696, a bias member 607, a first needle 665, a secondneedle 669, a membrane 668, an air inlet 667, a vial 640, a transferguard 660, and a filter 662. The reservoir 680 may have a septum 684.The vial 640 may have a septum 644. The system 600 may be configuredsuch that in a case where the vial 640 is inverted and the second needle669 is inserted into the vial 640, the second needle 669 vents toatmosphere from the air inlet 667 to a headspace 647 in the vial 640above an area 645 of the vial 640 that contains fluidic media. Thus, byusing the second needle 669 to vent the headspace 647 of the vial 640 toatmosphere, there may be substantially no percolation of air throughfluidic media in the vial 640.

In various embodiments, the system 600 may be configured such that in acase where the vial 640 is inverted and the second needle 669 isinserted into the vial 640, the second needle 669 vents to atmospherefrom the air inlet 667 to the area 645 of the vial 350 that containsfluidic media. Thus, the second needle 669 in the vial 640 may providefor atmospheric pressure in the vial 640.

The membrane 668 may be a hydrophobic membrane. The hydrophobic membrane668 may substantially reduce an addition of water vapor through thesecond needle 669 to the vial 640. The system 600 may be configured suchthat as fluidic media is drawn into the reservoir 680, it passes throughthe filter 662, which may comprise a membrane, such as a hydrophobicmembrane or a hydrophilic membrane, to filter out air bubbles and/ordegas the fluidic media drawn into the reservoir 680. Additionally,water vapor may be restricted from entering the vial 640 through thesecond needle 669 by the hydrophobic membrane 668. In variousembodiments, equalizing a pressure of the vial 640 with an atmosphericpressure may help to prime the vial 640. In other embodiments, themembrane 668 may be a hydrophilic membrane.

In various embodiments, the plunger arm 694 and the handle 696 may beconfigured such that the plunger arm 694 is able to snap together orotherwise connect with the handle 696 to connect the plunger arm 694 tothe handle 696. In various other embodiments, the plunger arm 694 andthe handle 696 may be configured to be connected in other ways, such asby screwing the plunger arm 694 into the handle 696. In someembodiments, the handle 696 may be part of the plunger arm 694, and thehandle 696 may be connectable to the bias member 607. According to someembodiments of the system 600, the handle 696 may be connected to theplunger arm 694, and the plunger arm 694 may be connected to the plungerhead 690. In such an embodiment, movement of the handle 696 away fromthe reservoir 680 may cause the plunger head 690 to retract within thereservoir 680 to create a vacuum that enables a filling of the reservoir680 by drawing fluidic media from the vial 640.

In some embodiments, the bias member 607 may be a spring, or the like.The bias member 607 may be located between the plunger head 690 and anend 688 of the reservoir 680. The bias member 607 may be initially in anexpanded position. The bias member 607 may provide a retaining forcebehind the plunger head 690 in the reservoir 680 as the plunger head 690is moved within the reservoir 680. Movement of the handle 696 away fromthe reservoir 680 may move the plunger head 690 within the reservoir 680and compress the bias member 607 to a compressed position.

In various embodiments, a tension of the bias member 607 may be selectedso as to allow for the reservoir 680 to fill at different rates when thebias member 607 compresses depending on the tension of the bias member607. Thus, the system 600 may allow for a vial pressure equalizer usingthe second needle 669, with a bias member 607 to assist movement of theplunger head 690, and a filter 662 to filter air bubbles out of fluidicmedia as the fluidic media is filled into the reservoir 680.

In various embodiments, the fill volume control 230 (FIGS. 11-14 and 16)may be used with embodiments of the systems described above, and/or maybe provided at various locations of those embodiments. For example, withreference to FIGS. 17-21, a fill volume control, such as the fill volumecontrol 230 (FIGS. 11-14 and 16) described above, may be provided in anarea 321 of the system 300 such that the fill volume control ispositioned between the first housing portion 302 and the second housingportion 322. In such an example, the fill volume control may allow forthe system 300 to transfer fixed volumes of fluidic media during afilling process as previously described.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

What is claimed is:
 1. A system for transferring fluidic media, thesystem comprising: a housing portion for receiving a reservoir connectedto a vial through a transfer guard; a bias member held by the housingportion and arranged to provide a bias force directed to change arelative position of a plunger head within an interior volume of thereservoir, when the reservoir is received by the housing portion;wherein the housing portion and the bias member are configured totransfer fluidic media between the vial and the reservoir, through thetransfer guard, when the transfer guard is connected to the reservoirand the vial, the reservoir is received by the housing portion, and thebias force of the bias member changes the relative position of theplunger head within the interior volume of the reservoir.
 2. A systemaccording to claim 1, further comprising the transfer guard, wherein thetransfer guard is connected to and provides a fluid flow path betweenthe reservoir and the vial.
 3. The system according to claim 1, furthercomprising: a latch for holding the bias member in a first state, andfor selectively releasing the bias member to move to a second stateunder the bias force to change the relative position of the plunger headwithin an interior volume of the reservoir.
 4. The system according toclaim 1, wherein the bias member comprises a spring.
 5. The systemaccording to claim 1, further comprising a handle movably held by thehousing portion and operatively engageable with the plunger head, thehandle arranged to receive the bias force from the bias member formoving the handle to change the relative position of the plunger headwithin the interior volume of the reservoir.
 6. The system according toclaim 5, wherein the housing portion and the bias member are configuredsuch that fluidic media is transferred from the vial to the reservoir ina case where the reservoir is received by the housing portion, thehandle is operatively engaged with the plunger head, and the handle ismoved to change the relative position of the plunger head within theinterior volume of the reservoir.
 7. The system according to claim 5,further comprising: a latch for supporting the handle when the latch isin a first position, and for releasing the handle to allow the handle tomove when the latch is moved to a second position; the bias memberbiased toward an expanded position and held compressed by the handle ina case where the latch is in the first position and the latch issupporting the handle; and the bias member pushes on the handle so as tomove the handle in a case where the latch is moved to the secondposition to release the handle.
 8. The system according to claim 5,further comprising: a plunger arm having a first end and a second end,the first end of the plunger arm connectable to the plunger head, thesecond end of the plunger arm connectable to the handle.
 9. The systemaccording to claim 5, wherein the bias member comprises a spring. 10.The system according to claim 1, further comprising a second housingportion for supporting the transfer guard, wherein the bias member isarranged to provide the bias force in a direction to change a relativeposition of the second housing portion and the housing portion forreceiving the reservoir.
 11. The system according to claim 10, whereinthe housing portion for receiving the reservoir is coupled to hold theplunger of the reservoir while the bias member changes the relativeposition of the second housing portion and the housing portion forreceiving the reservoir.
 12. The system according to claim 11, furthercomprising the transfer guard, wherein the transfer guard is connectedto and provides a fluid flow path between the reservoir and the vial,and wherein the transfer guard is configured to connect to a body of thereservoir, to move the body of the reservoir relative to the plunger ofthe reservoir, when plunger of the reservoir is held by the housingportion for receiving the reservoir and the bias force changes therelative position of the second housing portion and the housing portionfor receiving the reservoir.
 13. A method for transferring fluidicmedia, the method comprising: receiving a reservoir by a housingportion; connecting a transfer guard to provide a fluid path from a vialto the reservoir; arranging a bias member in the housing portion toprovide a bias force directed to change a relative position of a plungerhead within an interior volume of the reservoir, when the reservoir isreceived by the housing portion; changing the relative position of theplunger head within the interior volume of the reservoir by the biasforce of the bias member to transfer fluidic media between the vial andthe reservoir, when the transfer guard is connected to the reservoir andthe vial, and the reservoir is received by the housing portion.
 14. Themethod according to claim 13, further comprising: holding the biasmember in a first state with a latch, and selectively releasing the biasmember with the latch, to move the bias member to a second state underthe bias force to change the relative position of the plunger headwithin an interior volume of the reservoir.
 15. The method according toclaim 13, further comprising: holding a moveable handle with the housingportion; operatively engaging the handle with the plunger head;arranging the handle to receive the bias force from the bias member formoving the handle to change the relative position of the plunger headwithin the interior volume of the reservoir.
 16. The method according toclaim 15, further comprising moving the handle under the bias force ofthe bias member to change the relative position of the plunger headwithin the interior volume of the reservoir.
 17. The method according toclaim 15, further comprising: supporting the handle against the biasforce of the bias member with the latch is in a first position; movingthe latch to a second position to release the handle to allow the handleto move under the bias force of the bias member, to change the relativeposition of the plunger head within an interior volume of the reservoir.18. The method according to claim 15, wherein the bias member comprisesa spring, the method further comprising: providing a latch having afirst state and a second state; holding the spring in a compressed stateby the handle in a case where the latch is in the first state; andreleasing the spring from the compressed state to move the handle in acase where the latch is in the second state.
 19. The method according toclaim 13, further comprising supporting the transfer guard with a secondhousing portion, wherein the bias member is arranged to provide the biasforce in a direction to change a relative position of the second housingportion and the housing portion receiving the reservoir.
 20. The methodaccording to claim 19, further comprising coupling the plunger of thereservoir to the housing portion receiving the reservoir; and operatingthe bias member to change the relative position of the second housingportion and the housing portion receiving the reservoir.